The Houston Methodist Hospital first general hospital in Texas to treat a patient with the remedē® System
The Houston Methodist Hospital is the first hospital in Texas (outside the Veterans Affairs system) to treat a patient with remedē, a first of its kind treatment for adult patients with central sleep apnea
Respicardia, Inc. announced today that The Houston Methodist Hospital is the first hospital in Texas (outside the Veterans Affairs system) to treat a patient with the remedē® System, an implantable device that uses phrenic nerve stimulation to treat central sleep apnea (CSA) in adult patients. Dr. Paul Schurmann, an electrophysiologist at The Houston Methodist, successfully performed the procedure for a patient suffering from severe Central Sleep Apnea.
“Sleep disordered breathing affects many of our cardiology patients, often increasing their symptoms of fatigue and lethargy. Central sleep apnea can be particularly difficult to treat. As an electrophysiologist, it is exciting to be able to collaborate with our sleep medicine colleagues to offer phrenic nerve stimulation to our patients in need,” says Dr. Paul Schurmann. Nikki Washington, Director of Nursing Cardiac Cath Lab Services adds, “We are eager to be a leader in offering this new innovative therapy. Therapeutic sleep is critical for patients, and phrenic nerve stimulation has been shown to help patients achieve therapeutic levels and feel better.”
“The patient was referred to us because of discouraging symptomatic relief and objective outcomes despite committed adherence to treatment with CPAP and specialized BiPAP machines. Having this option for treatment was life-changing for him.” says Dr. Sudha Tallavajhula, referring sleep medicine physician.
The remedē system is an implantable device that activates automatically each night to stimulate a nerve in the chest (phrenic nerve) that sends signals to the breathing muscles (diaphragm) to control breathing. It monitors respiratory signals and helps restore normal breathing patterns1. The remedē System received U.S. Food and Drug Administration (FDA) approval in October 2017 and is commencing market release in a limited number of centers in the United States and Europe.2
“Congratulations to Dr. Schurmann and the Methodist team, as well as Dr. Tallavajhula, for ensuring this novel therapy was made available to a patient in need,” said Peter Sommerness, President and CEO of Respicardia. “The Houston Methodist Hospital prides itself in being a leader, and offering cutting edge therapies like remedē shows how invested they are in providing the very best care for their patients.”
About Central Sleep Apnea (CSA) and the remedē® System
Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and results from the brain’s inability to send appropriate signals to the respiratory muscles to stimulate breathing. People with CSA often suffer from chronic fatigue, excessive daytime sleepiness, memory and concentration problems, and depression, which substantially reduce quality of life. Untreated CSA has also been shown to be associated with higher rates of heart failure and atrial fibrillation.3,4
The remedē System treats the harmful effects of CSA by restoring a more normal breathing pattern during sleep. The remedē System pivotal clinical trial, published in The Lancet, demonstrated that transvenous neurostimulation with the remedē System can significantly reduce the severity of CSA, improve sleep, and improve both quality of life and patient satisfaction. Recently published data in the American Journal of Cardiology (12 month follow-up data) and SLEEP (24 and 36 month follow-up data) demonstrate continued, long term efficacy of the therapy.1,5,6
Respicardia is a leader in innovative technologies that address the unmet needs in respiratory and cardiovascular disease with safe and effective therapies. Founded in 2006 and headquartered near Minneapolis, Minn., Respicardia is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel transvenous neurostimulation therapies. Learn more at www.respicardia.com.
Important safety information
The remedē® System is indicated for moderate to severe Central Sleep Apnea in adult patients.
Your doctor will need to evaluate your condition to determine if the remedē system is right for you. You will not be able to have an MRI or diathermy (special heat therapies) if you have the remedē system implanted. The remedē System may be used if you have another stimulation device such as a heart pacemaker or defibrillator; special testing will be needed to ensure the devices are not interacting.
As with any surgically implanted device, there are risks related to the surgical procedure itself which may include, but are not limited to, pain, swelling, and infection.
Once the therapy is turned on, some patients may experience discomfort from stimulation and/or from the presence of the device. The majority of these events are resolved either on their own or by adjusting the therapy settings. The remedē system may not work for everyone. There are additional risks associated with removing your system. If you and your doctor decide to remove the system, another surgery will be required.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the remedē System. Rx only. For further information, please call +1-952-540-4470 or email email@example.com.
1 Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82
2 FDA PMA P160039 https://www.fda.gov/medical-devices/recently-approved-devices/remeder-system-p160039
3 May A.M., Blackwell T., Stone P.H., et al., for the MrOS Sleep (Outcomes of Sleep Disorders in Older Men) Study Group (2016) Central sleep-disordered breathing predicts incident atrial fibrillation in older men. Am J Respir Crit Care Med 193:783–791
4 Javaheri S., Blackwell T., Ancoli-Israel S., et al., for the Osteoporotic Fractures in Men Study Research Group (2016) Sleep-disordered breathing and incident heart failure in older men. Am J Respir Crit Care Med 193:561–568.
5 Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol. 2018. pii: S0002-9149(18)30258-3. doi: 10.1016/j.amjcard.2018.02.022.
6 Fox H, Oldenburg O, Javaheri S, et al. remedē® System Pivotal Trial Study Group, Long-term Efficacy and Safety of Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea Outcomes of Phrenic Nerve Stimulation for Central Sleep Apnea, Sleep. doi.org/10.1093/sleep/zsz158.